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Fixed Dose, Single Pill Truvada Preferred to TDF+FTC
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Virologic suppression is maintained in antiretroviral experienced adults who change from tenofovir and lamivudine to Truvada, a once daily fixed-dose combination tablet of tenofovir and emtricitabine; and 100% of patients preferred convenience of a simplified single pill, Fixed Dose Combination
Reported by Jules Levin
8th Intl Congress on Drug therapy in HIV Infection, Glasgow, UK, Nov 12-16, 2006
Amy E Colson, Calvin J Cohen, Claudia Martorell, Robert C Stevens, Karen McLaughlin. Community Research Initiative of New England, Boston, MA, USA; Community Research Initiative of New England, Springfield, MA, USA; Gilead Sciences, Foster City, CA, USA
The convenience and tolerability of antiretroviral regimens may be improved by coformulated medications which reduce pill burden. Truvada is a combination tablet of tenofovir (TDF) and emtricitabine (FTC). This study evaluated antiretroviral activity, safety, and patient acceptance in individuals who changed from TDF and lamivudine (3TC) to Truvada.
This 24-week prospective study enrolled 20 HIV+ adults with undetectable viral load (VL) on a stable regimen including TDF and 3TC for at least 90-days. At enrollment, subjects changed from TDF and 3TC to Truvada.
At baseline: mean age 46; 75% with prior AIDS diagnosis; mean CD4 563; mean creatinine (Cr) 1.0 mg/dl; 10 subjects on PI-based regimens, 9 on NNRTI-based regimens, and 1 on both a PI and NNRTI.
One subject missed her week 4 visit, one terminated at week 20 (with VL< 75) due to relocation and one changed back to TDF and 3TC at wk 18 (with VL< 75) due to rash.
At weeks 4 and 24, 100% on Truvada maintained a viral load < 75 (week 4: 19/19 = 100% suppressed, 95% CI 85-100%; wk 24: 18/18 = 100% suppressed, 95% CI 85-100%).
There was no significant change in CD4 or Creatinine during the study.
At week 4, 100% of the patients agreed (84% strongly, 11% moderately, 5% mildly) that "taking the single Truvada tablet is more convenient that taking separate Epivir and Viread pills" and 84% preferred taking the single Truvada tablet.
Changing TDF and 3TC to Truvada maintained virologic suppression. Four weeks after the change, 100% of participants found Truvada to be more convenient.
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